About this trial
Early support is thought to be key to ensure a better quality of life for young children on the autism spectrum. Among early support, different evidence-based approaches have combined the principles of developmental and behavioral science within a naturalistic and interactive frame and grouped under the umbrella of Naturalistic Developmental Behavioral Interventions (NDBI). In the context of NDBIs, the Early Start Denver Model is a manualized support that has reported evidence of efficacy for therapist-, group- and caregiver-implemented support, in multiple research as well as community based settings, different countries and languages (Rogers \& Dawson, 2010). Understanding the effects of support characteristics and intensity on individual learning has a major impact on the delivery systems organization and policies, sustainability in low resources community settings and to provide the necessary support to the family. However, a direct comparison among different types and intensity of early support in community setting and relatively low access to standardized and intensive programs, have not been adequately explored. For this reason, the aim of this study is to investigate, in a community setting in the Italian context, the impact of ESDM and support intensity on individual developmental trajectories.
Eligibility criteria
Qualifiers
unimpaired hand use
parent agreement to have a caregiver present during all home sessions
attendance at all intake sessions
permission to videotape evaluations and ESDM treatment
Disqualifiers
serious parental substance abuse
parental self-report of bipolar disorder or psychosis
known genetic syndromes
serious medical conditions (e.g., encephalitis, concussion, seizure disorder)
Trial design
Treatments tested in this trial
- Early Start Denver Model (ESDM)
Treatment groups
Sponsors and collaborators
Istituto per la Ricerca e l'Innovazione Biomedica
Lead sponsor
Istituto Superiore di Sanità
Collaborator
Messina, Italy
Collaborator
Società Cooperativa Sociale AUDACIA
Collaborator
Associazione Ulisse
Collaborator
La Linea Curva
Collaborator